New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography

NCT ID: NCT02240745

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-11-30

Brief Summary

The investigators are going to recruit patients who have a scheduled elective coronary angiography and going to do a dobutamin stress echography (DSE) before the coronary examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE, incl ventriculography. In the interventional part (coronary angiography), they will measure each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.

Detailed Description

Background

Coronary heart disease is the leading cause of death worldwide. Non-invasive, radiation-free diagnostic needs further improvement. In this study, the investigators test the hypothesis that their method, which measures the myocardial deformation using 3D echocardiography is superior to previous ultrasound technologies with regard to diagnosis of stable coronary artery disease. The aim is establish an improved, non-invasive method to diagnose stable coronary artery disease.

Objective

The investigators want to investigate if a 3D-speckle-tracking is superior and more accurate in predicting hemodynamically significant coronary artery stenosis than predicted by 2D echocardiography? The reference variable for the hemodynamic significance of coronary artery stenosis is invasively measured by coronary flow reserve (CFR) in consideration of collateral flow (CFI).

Methods

This is a prospective observational study. The investigators will include 100 persons who are scheduled for an elective coronary angiography.

A regular 2D-stress echocardiography according to the international guidelines will be performed (incl. PLAX, SAX, 2CV, 4CV). The classification of regional wall motion abnormality is carried out according to the internationally recognized standards in 16 myocardial segments of the LV, with a grading of wall thickening (0 = dyskinetic, akinetic = 1, 2 = hypokinetic, 3 = normal). In addition, a 3D speckle tracking is performed after data transfer. To determine the functional relevance of any stenosis (reference method) a flow reserve in a maximum of two coronary arteries will be performed.

Test accuracy of 2D stress echocardiography and the new 3D method for detecting a significant stenosis (CFI <2) are then compared.

Conditions

Coronary Artery Disease; Echocardiography, Stress

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

All patients

Patients with a suspicion of coronary heart disease

Stress-echocardiography

Intervention Type: OTHER

Stress-echocardiography (incl dobutamin and atropin)

Interventions

Stress-echocardiography

Stress-echocardiography (incl dobutamin and atropin)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Scheduled elective coronary angiography
• Age >/= 18 years
• Written informed consent

Exclusion Criteria

• Age < 18 years
• Acute coronary syndrome
• Unstable angina pectoris
• Coronary 3-vessel disease
• Left-main artery affected
• Situation after myocardial infarction
• Coronary anomaly
• Situation after coronary bypass
• Congenital heart disease
• Pacemaker
• Any contraindication concerning stress-echo

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano de Marchi, Senior consultant

Role: PRINCIPAL_INVESTIGATOR

Dept. of Cardiology, University Hospital of Bern, Bern

Locations

Dept of Cardiology, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

References

Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.

Reference Type: BACKGROUND

PMID: 23996286 (View on PubMed)

Doucette JW, Corl PD, Payne HM, Flynn AE, Goto M, Nassi M, Segal J. Validation of a Doppler guide wire for intravascular measurement of coronary artery flow velocity. Circulation. 1992 May;85(5):1899-911. doi: 10.1161/01.cir.85.5.1899.

Reference Type: BACKGROUND

PMID: 1572046 (View on PubMed)

Traupe T, Gloekler S, de Marchi SF, Werner GS, Seiler C. Assessment of the human coronary collateral circulation. Circulation. 2010 Sep 21;122(12):1210-20. doi: 10.1161/CIRCULATIONAHA.109.930651. No abstract available.

Reference Type: BACKGROUND

PMID: 20855668 (View on PubMed)

Meuwissen M, Siebes M, Chamuleau SA, Tijssen JG, Spaan JA, Piek JJ. Intracoronary pressure and flow velocity for hemodynamic evaluation of coronary stenoses. Expert Rev Cardiovasc Ther. 2003 Sep;1(3):471-9. doi: 10.1586/14779072.1.3.471.

Reference Type: BACKGROUND

PMID: 15030274 (View on PubMed)

Varga A, Garcia MA, Picano E; International Stress Echo Complication Registry. Safety of stress echocardiography (from the International Stress Echo Complication Registry). Am J Cardiol. 2006 Aug 15;98(4):541-3. doi: 10.1016/j.amjcard.2006.02.064. Epub 2006 Jun 28.

Reference Type: BACKGROUND

PMID: 16893714 (View on PubMed)

Other Identifiers

SNCTP 0761

Identifier Type: OTHER

Identifier Source: secondary_id

039/14

Identifier Type: -

Identifier Source: org_study_id